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Clinical Trial Details

Trial ID: L2425
Source ID: NCT02533648
Associated Drug: 2 Capsules Of Allopurinol 150 Mg Daily For 3 Month
Title: Role of Allopurinol on Oxidative Stress and Mitochondrial Alterations in Skeletal Muscle of Diabetic Patients
Acronym: DIAXO
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: 2 capsules of allopurinol 150 mg daily for 3 month|DRUG: 2 capsules of lactose daily for 3 month
Outcome Measures: Primary: muscle oxidative stress in diabetic patients, muscular protein carbonylation level (unit: reactive carbonyl derivates, arbitrary unit) by Western blot (oxyblot kit from Chemicon) and pro et antioxidant genes expression (unit: mRNA levels normalized by housekeeping gene, arbitrary ratio) by real time polymerase chain reaction (RT-PCR), At 3 months of treatment | Secondary: - plasmatic oxidative stress by dosing plasmaticmarkers:, Dosing plasmatic malondialdéhyde, plasmatic H2O2, protein carbonylation of plasmatic protein and urinary isoprostans, and finally antioxidants (vitamins C and E, glutathione (unit: from µM to M), At 3 months of treatment|alterations in mitochondrial structure of skeletal muscle with transmission electron microscopy, Analysis of mitochondria area (in µm2) and density (in %), At 3 months of treatment|mitochondrial density by measuring the ratio mitochondrial Deoxyribonucleic acid (mtDNA)/nuclear DNA by real-time polymerase chain reaction (PCR) in skeletal muscle, At 3 months of treatment|mitochondrial function, Expression of genes implicated in mitochondrial action (messenger Ribonucleic acid (mRNA) levels by Reverse transcription polymerase chain reaction (RT-PCR) and proteins levels by Western Blot)(unit: arbitrary ratio relative to housekeeping gene/protein)., At 3 months of treatment|quantification of intramuscular lipids by histology (biopsy analysis), Staining Oil Red O evaluate the intramuscular lipid accumulation using the software ImageJ(unit: % of labelling by field)., At 3 months of treatment|sensitivity to insulin using a hyperinsulinemic euglycemic clamp, sensitivity to insulin will be expressed as the glucose infusion rate (GIR)/insulinemia ratio., At 3 months of treatment|uricemia and xanthine oxidase activity in sera and muscles(unit: mg/l for uricemia and mU/ml for XO activity), Plasma concentrations of uric acid will be measured before and after treatment to assess patient compliance . The reduction of xanthine oxidase activity in serum and muscle protein lysates will be measured using the kit " Amplex Red xanthine / xanthine oxidase assay kit" from Molecular Probes, At 3 months of treatment|Tolerance of the treatment measured by any adverse events during treatment and between each visit., Any adverse events during treatment and between each visit., during the 3 months of treatment
Sponsor/Collaborators: Sponsor: Hospices Civils de Lyon
Gender: ALL
Age: ADULT
Phases: PHASE3
Enrollment: 31
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2011-09-16
Completion Date: 2016-02-18
Results First Posted:
Last Update Posted: 2019-11-01
Locations: CRNH Rhône Alpes, Lyon, 69310, France
URL: https://clinicaltrials.gov/show/NCT02533648